Lupin gets USFDA warning letter for Mandideep Unit-1 facility

Commenting on the same, Lupin said, "The Company does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of this facility."

Mumbai: Drug firm, Lupin Ltd. today said it has received a warning letter from the U.S. Health regulator for its Mandideep (Unit-1) facility.

This is subsequent to an earlier intimation received from the U.S. Food and Drug Administration (USFDA) in March 2019 wherein the agency had classified its inspection conducted at the said facility in December 2018 as "Official Action Indicated" (OAI).

There are no DMF and ANDA applications pending review or approval from the Mandideep (Unit-1) facility.

Commenting on the same, Lupin said, "The Company does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of this facility."

"We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities, " Lupin added.

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Based in Mumbai, the company’s key focus areas include paediatrics, cardiovascular, anti-infectives, diabetology, asthma, and anti-tuberculosis.

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